Responsibilities: Resolution of fundamental Computer System Validation compliance issues on assigned projects. Writing, reviewing, and executing computer validation documentation. Perform computer system validation activities related to process control systems of pharmaceutical water for injection system, water pretreatment system, water stills and high-quality steam generation systems. Validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report). ssessing electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach to suggest the most appropriate mitigation/remediation actions. Ensuring that all project-related issues and deviations are recorded, approved and dispensed accordingly. Preparation of project and life-cycle reports and review/approve all other documents to ensure compliance with SOP. Ensuring that all project and lifecycle documents achieve the goal of traceability, and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP. Requirements: t least 8 years s of experience in the pharmaceuticals field, with focus on Computer System Validation. Previous work experience in computer system validation of PLC's, HMI's, SCADA and historian. Experienced in computer system validation of Rockwell Factory Talk, Microsoft SQL Server, Microsoft NET Framework and Allen Bradley PLC systems preferably related to process control systems. bility to perform input and output testing. Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and process control systems. Strong knowledge in good documentation practices. Knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11. Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11). Katalyst Healthcares and Life Sciences
...Job Description Job Description Auto body repair, including: panel repair / panel replacement spot welding & resistance welding... ...Company Description One of the best customer rated Auto body shops in Canada. Established in Airdrie Alberta July 2016 and growing...
...accessible and expanded access to care for our patients in the San Lorenzo Valley. Driven by our commitment to health care as a human right, SCCH is a leading non-profit provider offering comprehensive health services to our patients, regardless of their ability to pay...
Job Description Job Description Responsibilities 1. Mainly responsible for sales management and channel development of regional KA customers. 2. Inventory management and sales data management: track customer inventory data in time, remind customers to replenish...
...Phalanx Griffon (PG) is the Air Forces openarchitecture airborne node linking warfighters to decisionquality data at the tactical edge. As the programs Avionics Engineering SME , you will be the cornerstone technical authority for integrating the Nomad chassis,...
...Picker/Packers for inbound operations at a fast-paced apparel warehouse in North East, Maryland. This position involves unloading,... ...Why Join Us? Weekly pay $19/hour Set schedule with your weekends starting Friday night Clean, well-organized facility with a...